Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
All TitlesTitle 21Chapter IPart 820Subpart A - Subpart A—General Provisions
View all text of Subpart A [§ 820.1 - § 820.5]
§ 820.5 - Quality system.

Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.

authority: 21 U.S.C. 351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383; 42 U.S.C. 216,262,263a,264
source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.
cite as: 21 CFR 820.5
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